Anvisa allows a new phase of Brazilian vaccine testing against Covid | Science and health

The National Health Surveillance Agency (Anvisa) has authorized the start of a new phase of clinical trials of a candidate vaccine against COVID-19 developed by the Federal University of Minas Gerais (UFMG). The study is funded by the university, the Ministry of Science, Technology and Innovation, the Oswaldo Cruz Foundation (Fiocruz) and the Belo Horizonte City Hall.

And Anfisa stated in a note that the start of the first phase of the clinical trial was approved by the agency in October 2022, and based on the preliminary results related to safety and immunogenicity obtained, the clinical trial was allowed to continue for the next phase. “The goal of this new phase is to obtain additional safety and immunogenicity data using the dose that provided the best phase 1 performance,” the note says.

Also, according to the agency, this new phase will include healthy participants of both sexes, between the ages of 18 and 85, who have completed the initial vaccination schedule against the Corona virus using the CoronaVac or Coveshield vaccines, after they have received one or two booster doses. With Covishield or Comirnaty for at least 6 months. Participants may have had a previous natural infection with MERS-CoV for at least 6 months from the date of their inclusion.

The clinical trial, according to Anvisa, is being conducted at three centers in Belo Horizonte: at the UFMG School of Medicine, at the Freer Clinical Research Center, and at the Infection Control Center. 372 volunteers will be recruited, and the centers conducting the research will be responsible for recruitment. The deadline to start the clinical trial is determined after ethical and regulatory approval by the trial sponsor.